MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI VECTRA(TM) PLATE 4 LEVEL/84MM; APPLIANCE,FIXATION,SPINAL INTERVERTEBRAL BODY

Model Number	04.613.384
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history records has been requested.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that during an anterior cervical fusion procedure on (b)(6) 2018, one (1) titanium vectra plate had a defective locking mechanism.Five (5) titanium cervical self-retain screws were also used.When placing the fifth screw, the elgiloy clip of the plate on the locking mechanism broke.The plate and all five (5) screws were then removed.It was an issue with the clip not with the screws.The plate was removed and a competitor¿s plate was used to complete the procedure successfully with no patient harm.Concomitant device: 4.0mm titanium cervical self-retain screw 16mm (part 04.613.616, lot unknown, quantity 5).This report is for one (1) titanium vectra plate.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.A device history record (dhr) review was conducted: part: 04.613.834.Lot: 1453495.Manufacturing site: mezzovico.Release to warehouse date: 20.Feb.2006.The device history record shows this lot of 9 pieces was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional and visual criteria at the time of release with no issues documented during the manufacturing process.This implant was manufactured from forging blank 50152234 lot 1426203.Part: 50152234.Lot: 1426203.Manufacturing site: mezzovico.Release to warehouse date: 20.Dec.2005.The device history record shows this lot of 120 pieces was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.The raw material certificate 7511 was reviewed and the used material was according to iso-5832-11 specification for implants for surgery.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.A product investigation was conducted.Visual inspection: the ti vectra plate (part # 04.613.384, lot # 1453495, mfg # 20-feb-2006) was received at us cq with visible signs of wear.The wishbone clips on 4 of 10 holes were significantly deformed and 1 was completely missing.The plate shows visible signs of implantation and explantation.The wishbone clip that the surgeon complained about is significantly deformed and is protruding out, however, it did not break.Therefore, the complaint cannot be confirmed for breakage but is confirmed for deformation.Dimensional inspection: dimensional analysis was not performed as the relevant features are significantly deformed.Document/specification review: the relevant drawing(s) was reviewed; conclusion: the complaint condition is confirmed as the ti vectra plate (part # 04.613.384, lot # 1453495) was received with some of the wishbone clips on the vectra plate deformed.There is no indication that a design or manufacturing issue contributed to the complaint.While no definitive root cause could be determined it is possible that the device encountered unintended forces.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: TI VECTRA(TM) PLATE 4 LEVEL/84MM
• Common Device Name: APPLIANCE,FIXATION,SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7958625
• Report Number: 2939274-2018-54345
• Device Sequence Number: 13525198
• Product Code: KWQ
• UDI-Device Identifier: 10705034737553
• UDI-Public: (01)10705034737553
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K050451
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.613.384
• Device Catalogue Number: 04.613.384
• Device Lot Number: 1453495
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2018
• Initial Date Received by Manufacturer: 09/25/2018
• Supplement Date Received by Manufacturer: 11/15/2018
• Initial Report FDA Received Date: 10/11/2018
• Supplement Report FDA Received Date: 11/15/2018
• Patient Sequence Number: 1